Medical devices policy and the humanities: Xamining implantable cardiac devices

Medical devices are ubiquitous: eyeglasses and intraocular lenses enhance vision; artificial limbs restore mobility; and implanted pacemakers and defibrillators treat otherwise debilitating or fatal heart rhythms. Despite the critically important role of medical devices in health care, their development, testing, and use raise significant practical and normative issues. For the most part addressing these issues in the context of medical device policy is quite straightforward. It seems fair to claim that the overwhelming majority of regulators, payers, and patients do not regard most implanted medical devices as significant alterations posing challenges to the integrity of the individual or the species. The prospect or actual failure of an incorporated medical device can at times loom large in patients’ perceptions, but in general, most devices have not presented unique moral or ethical challenges relative to other interventions such as those involving genetics or reproduction. Medical device research and development instead provides a somewhat specialized example of the relevance of the humanities in general, and of ethics in particular, to medical research and medical products. In addition, examining this example in detail may challenge the conclusions made in other settings where technology is incorporated into humans and nature is thereby considered to be altered.